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Intra-Articular Injections of Platelet-Rich Plasma in Knee Osteoarthritis: Unique Application Versus Triple Application

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ClinicalTrials.gov Identifier: NCT02370420
Recruitment Status : Completed
First Posted : February 25, 2015
Results First Posted : February 19, 2018
Last Update Posted : February 19, 2018
Sponsor:
Information provided by (Responsible Party):
FELIX VILCHEZ CAVAZOS, Universidad Autonoma de Nuevo Leon

Brief Summary:
The investigators include patients attending the outpatient clinic in the area of Orthopedics and Traumatology of the investigators hospital with a diagnosis of knee osteoarthritis, which treatment is medical. Patients will be divided into two groups. In both groups, they will be given verbal, clear and detailed information on the approach to follow, the intra-articular application of Platelet-Rich Plasma in the knee, plus rehabilitation exercises. In the first group will be held single application, while in the second group three applications will be made at an interval of two weeks each. Both groups will be assessed before and after application, together with outpatient follow-up by the SF-12 Health Survey (SF-12), Western Ontario and McMaster Universities Arthritis Index (WOMAC) and Visual Analogue Scale (VAS).

Condition or disease Intervention/treatment Phase
Osteoarthritis Biological: Platelet-Rich Plasma Behavioral: rehabilitation exercises Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intra-Articular Injections of Platelet-Rich Plasma in Knee Osteoarthritis: Unique Application Versus Triple Application
Actual Study Start Date : March 2015
Actual Primary Completion Date : July 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Unique application of PRP
Patients will be applied a unique application of platelet-rich plasma for knee osteoarthritis, and will be given rehabilitation exercises at home
Biological: Platelet-Rich Plasma
Autologous Platelet-Rich Plasma will be applied by a intra-articular injections

Behavioral: rehabilitation exercises
Patients would been shown rehabilitation exercises, to perform them at home

Active Comparator: Triple application of PRP
Patients will be applied a triple application of platelet-rich plasma for knee osteoarthritis, with a interval of two weeks between each, and will be given rehabilitation exercises at home
Biological: Platelet-Rich Plasma
Autologous Platelet-Rich Plasma will be applied by a intra-articular injections

Behavioral: rehabilitation exercises
Patients would been shown rehabilitation exercises, to perform them at home




Primary Outcome Measures :
  1. Change in the Western Ontario and McMaster Universities (WOMAC) Ostearthritis Index (Therapeutic Effect) [ Time Frame: Baseline,3 weeks, 6 weeks, 12 weeks, 24 weeks ]

    The Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index is a widely used, proprietary set of standardized questionnaires used by health professionals to evaluate the condition of patients with osteoarthritis of the knee and hip, including pain, stiffness, and physical functioning of the joints. It measures five items of pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68); thus, the total score range is 0-96. A higher value indicates a worst outcome.

    Only the final measures (at 24 weeks) are presented as part of the final analysis.



Secondary Outcome Measures :
  1. Change in the SF-12 Health Survey (Quality of Life) [ Time Frame: Baseline,3 weeks, 6 weeks, 12 weeks, 24 weeks ]

    SF-12 scale is a generic, multipurpose short-form survey with 12 questions selected from the SF-36 Health Survey which, when combined, scored and weighted, results in two scales of mental and physical functioning and overall health-related quality of life.

    A higher value indicates a better quality of life of the patient. The scores range from 0 to 100. The data obtained with the SF-12 has been developed, tested and validated by Quality Metric Incorporated.

    Only the final measures (at 24 weeks) from the physical domain are presented as part of the final analysis.


  2. Change in the Visual Analog Scale (VAS) (Global Pain) [ Time Frame: Baseline,3 weeks, 6 weeks, 12 weeks, 24 weeks ]

    The Visual Analog Scale (VAS) is a unidimensional measure of pain intensity. The scale is most commonly anchored by "no pain " (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 10).

    Only the final measures (at 24 weeks) are presented as part of the final analysis.




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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age between 18 and 90 years
  • Patients with no previous treatment
  • Patients with Knee osteoarthritis grade 1-2 ( Kellgren-Lawrence based on radiographic findings)

Exclusion Criteria:

  • Age <18 and > 90 years
  • Patients with Knee osteoarthritis grade 3-4 ( Kellgren-Lawrence based on radiographic findings)
  • Patients with asociated Rheumatic syndromes
  • Patients with anticoagulant therapy
  • Patients with hepatic problems, Diabetes Mellitus, Coagulopathy, hearth conditions, immunodepressed, or infections
  • Pregnant patients
  • Patients with prosthetic or orthotic.
  • Patients with hemoglobin values < 11g/dl , platelets < 150,000/μL

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02370420


Locations
Mexico
Facultad de Medicina UANL
Monterrey, Nuevo Leon, Mexico, 66235
Sponsors and Collaborators
Universidad Autonoma de Nuevo Leon
Investigators
Principal Investigator: Felix Vilchez, MD, PHD Universidad Autonoma de Nuevo Leon

Publications of Results:

Responsible Party: FELIX VILCHEZ CAVAZOS, Dr. med. Jose Felix Vilchez Cavazos, Universidad Autonoma de Nuevo Leon
ClinicalTrials.gov Identifier: NCT02370420     History of Changes
Other Study ID Numbers: OR15-002
First Posted: February 25, 2015    Key Record Dates
Results First Posted: February 19, 2018
Last Update Posted: February 19, 2018
Last Verified: August 2017

Keywords provided by FELIX VILCHEZ CAVAZOS, Universidad Autonoma de Nuevo Leon:
Platelet-rich plasma
Osteoarthritis

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases